SPL v1
SPL
SPL Set ID 45f838e3-b643-2fdd-e063-6394a90a62f4
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hamamelis Virginiana (witch Hazel) Leaf Water (1.5 mg) Citrus Limon (lemon) Fruit Oil (0.6 mg) Citrus Paradisi (grapefruit) Seed Oil (0.15 mg) Lavandula Angustifolia (lavender) Oil (27.702 mg)
Inactive Ingredients
Glycerin Betaine Salicylate Aqua Disodium Edta-copper

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15

Description

HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT、LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL、CITRUS LIMON (LEMON) FRUIT EXTRACT、CITRUS PARADISI (GRAPEFRUIT) SEED OIL


Medication Information

Warnings and Precautions

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Indications and Usage

Please lie on your side before use, then take 3-4 drops of ear drops on the ear, let it stand for about 10 minutes, then wipe the dirt outside the cochlea with a cotton bail

Dosage and Administration

Please lie on your side before use, then take 3-4 drops of ear drops on the ear, let it stand for about 10 minutes, then wipe the dirt outside the cochlea with a cotton bail

Description

HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT、LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL、CITRUS LIMON (LEMON) FRUIT EXTRACT、CITRUS PARADISI (GRAPEFRUIT) SEED OIL

Section 44425-7

Store in a cool and dry place.

Section 50565-1

Please keep out of reach of children. Do not swallow.

Section 50566-9

Discontinue use if signs of irritation or rash occur.

Section 50567-7

Please lie on your side before use, then take 3-4 drops of ear drops on the ear, let it stand for about 10 minutes, then wipe the dirt outside the cochlea with a cotton bail

Section 50570-1

Discontinue use if signs of irritation or rash occur.

Section 51727-6

AQUA、GLYCERIN、BETAINE SALICYLATE、DISODIUM EDTA

Section 51945-4

Section 55105-1

1. Alleviate hearing impairment and restore hearing.

2. Completely cure the symptoms of tinnitus without recurrence.

3. Super powerful removal of deep dirt and blockage in the ear.

4. Before quickly treat ear inflammation and relieve pain.

Section 55106-9

HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT、LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL、CITRUS LIMON (LEMON) FRUIT EXTRACT、CITRUS PARADISI (GRAPEFRUIT) SEED OIL


Structured Label Content

Indications and Usage (34067-9)

Please lie on your side before use, then take 3-4 drops of ear drops on the ear, let it stand for about 10 minutes, then wipe the dirt outside the cochlea with a cotton bail

Dosage and Administration (34068-7)

Please lie on your side before use, then take 3-4 drops of ear drops on the ear, let it stand for about 10 minutes, then wipe the dirt outside the cochlea with a cotton bail

Warnings and Precautions (34071-1)

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Section 44425-7 (44425-7)

Store in a cool and dry place.

Section 50565-1 (50565-1)

Please keep out of reach of children. Do not swallow.

Section 50566-9 (50566-9)

Discontinue use if signs of irritation or rash occur.

Section 50567-7 (50567-7)

Please lie on your side before use, then take 3-4 drops of ear drops on the ear, let it stand for about 10 minutes, then wipe the dirt outside the cochlea with a cotton bail

Section 50570-1 (50570-1)

Discontinue use if signs of irritation or rash occur.

Section 51727-6 (51727-6)

AQUA、GLYCERIN、BETAINE SALICYLATE、DISODIUM EDTA

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

1. Alleviate hearing impairment and restore hearing.

2. Completely cure the symptoms of tinnitus without recurrence.

3. Super powerful removal of deep dirt and blockage in the ear.

4. Before quickly treat ear inflammation and relieve pain.

Section 55106-9 (55106-9)

HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT、LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL、CITRUS LIMON (LEMON) FRUIT EXTRACT、CITRUS PARADISI (GRAPEFRUIT) SEED OIL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)